ABSTRACT Background White spot lesions (WSL) may appear on teeth during fixed orthodontic treatment. Professionally administered topical fluorides play a key role in preventing such lesions. However, the evidence for their long‐term efficacy and patient‐reported outcomes is limited. Objective The primary objective was to evaluate the efficacy of topical fluorides (varnish vs. adhesive) in reducing the incidence of white spot lesions (WSLs) during and after 1 year of fixed orthodontic treatment. The secondary objectives were patient‐related outcomes, including perception of WSLs and adverse effects of the two agents. Trial Design Three‐arm, double‐blind, placebo‐controlled, single‐centre, single‐operator randomised controlled trial. Methods One hundred and fifty patients in the age group 14–20 years (mean age 17.98 ± 4.97) seeking fixed orthodontic treatment were randomly allocated into three groups. Group I ‐fluoride varnish ( Fluor‐Protector) , Group II‐ fluoride adhesive (Reliance Light bond TM), and Group III‐ Placebo. Patients were screened for WSLs at T0 (pre‐treatment), T1 (at debond), and T2 (one‐year follow‐up) using three methods: (i) laser‐induced fluorescence device (DIAGNOdent Pen), (ii) visual, and (iii) photographic methods. A 5‐point scale was used at T1 and T2 to evaluate the patient's perception. Results Fluoride varnish showed the least number of new WSLs and the least progression of WSLs (Group I–8.95%; Group II–20.82%; and Group III–20%). Most of the lesions developed in the anterior teeth. There was more than a 50% spontaneous reduction (remineralization) in WSLs, 1 year post debond (T1 vs. T2), signifying the tendency of remineralization irrespective of the fluoride prophylaxis given during treatment. Most patients (61.8%) did not notice the lesions at debonding, and the scores increased to 95.1% of patients not noticing these lesions. Conclusion 95% of patients do not notice WSLs after 1 year of debonding. Fluoride varnish was significantly more effective in preventing WSLs and could be considered during fixed orthodontic treatment, especially in patients with poor oral hygiene. There was no difference in remineralization in the three groups in the 1 year follow‐up period. Trial Registration The protocol was published in the clinical trial registry prior to the trial commencement (Clinical Trials Registry, Trial CTRI/2021/11/037918, URL: https://ctri.nic.in/Clinicaltrials/pmaindet2.php?EncHid=Mzc4OTA=&Enc=&userName= Registered on: 10/11/2021 ‐ Trial Registered Prospectively)
Izhar et al. (Thu,) studied this question.